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NCT07020117 · ClinicalTrials.gov registry record · Phase 1
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, sponsored by Aktis Oncology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 9
- Study locations
NCT07020117: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, sponsored by Aktis Oncology.
NCT07020117 is a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer that is actively recruiting participants, run by Aktis Oncology. The registered enrollment target is 150 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (77% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07020117, a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, is actively recruiting participants, sponsored by Aktis Oncology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
Primary Outcome
• Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT in Part 1, will be reported by dose level.
Conditions Studied
Interventions
- DRUG [225Ac]Ac-AKY-1189 (therapeutic)
- DRUG [64Cu]Cu-AKY-1189 (imaging)
Study Locations (9)
California
- City of Hope - Duarte
- Hoag Memorial Hospital Presbyterian - Irvine
Florida
- Biogenix Molecular, LLC - Miami
Iowa
- University of Iowa - Iowa City
Maryland
- United Theranostics - Glen Burnie
Michigan
- BAMF Health - Grand Rapids
New York
- Icahn School of Medicine at Mt. Sinai - New York
Pennsylvania
- UPMC - Pittsburgh
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-08-22 |
| Est. Completion | 2032-06 |
| Phase | Phase 1 |
What NCT07020117 shows while recruiting
NCT07020117 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (77% lower).
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which [225Ac]Ac-AKY-1189 (therapeutic) is the first listed.
NCT07020117 lists 9 locations in 8 states (California, Florida, Iowa).
Frequently Asked Questions
What is clinical trial NCT07020117 about?
NCT07020117 is a clinical study titled "A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors". This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administ...
What is the current status of trial NCT07020117?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2025-08-22. Estimated completion is 2032-06.
What conditions does trial NCT07020117 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Adenocarcinoma, Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC).
What interventions are being tested in trial NCT07020117?
The interventions under investigation include: [225Ac]Ac-AKY-1189 (therapeutic) (DRUG), [64Cu]Cu-AKY-1189 (imaging) (DRUG).
Who is sponsoring clinical trial NCT07020117?
This trial is sponsored by Aktis Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07020117 being conducted?
This trial has 9 study locations across California, Florida, Iowa, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07020117's enrollment target sits among peer trials
150 197th of 454 higher than 256 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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